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PREDNISOLONE SODIUM PHOSPHATE

ANDA

PREDNISOLONE SODIUM PHOSPHATE | A203559 | EDENBRIDGE PHARMACEUTICALS LLC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: PEDIAPRED(TE code: AA)

API Supply Chain5 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

EUROAPI FRANCEPREDNISOLONE SODIUM PHOSPHATE

DMF 40511981

CURIA SPAIN SAUPREDNISOLONE SODIUM PHOSPHATE

DMF 226242009

SYMBIOTEC PHARMALAB PRIVATE LTDPREDNISOLONE SODIUM PHOSPHATE USP

DMF 238992010

HENAN LIHUA PHARMACEUTICAL CO LTDPREDNISOLONE SODIUM PHOSPHATE USP

DMF 297512015

FARMABIOS SPAPREDNISOLONE SODIUM PHOSPHATE

DMF 401172024

ORGANON INCInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 7581963

ANTIBIOTICOS SPAInactivePREDNISOLONE SODIUM PHOSPHATE BULK

DMF 23761974

DIOSYNTHInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 38191980

PFIZER INCInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 93071991

NEWCHEM SPAInactivePREDNISOLONE SODIUM PHOSPHATE

DMF 218222008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 23, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — EQ 10MG BASE/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Dec 20, 2016

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE/5ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Dec 20, 2016

#003 — EQ 15MG BASE/5ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Feb 6, 2023

#004 — EQ 25MG BASE/5ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Feb 6, 2023